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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

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LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025 Back to Search Results
Model Number 14049543267
Device Problem Human Factors Issue
Event Date 08/03/2017
Event Type  Injury  
Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

 
Event Description

The customer reported that on (b)(6) 2017 they experienced suboptimal tissue processing on their leica asp6025. As a result some tissues were undiagnosable. Leica biosystems is trying to obtain the patient identifiers but at this time the customer is not able to provide this information, because to date no rebiopsy was required.

 
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Brand NameASP6025
Type of DeviceASP6025
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17-19
nussloch, 69226
GM  69226
Manufacturer (Section G)
LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.
12 teban gardens crescent
singapore, 60892 4
SN  608924
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch,  69226
  69226
MDR Report Key6809555
Report Number8010478-2017-00007
Device Sequence Number1
Product CodeIEO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number14049543267
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/22/2017 Patient Sequence Number: 1
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